MAUDE Adverse Event Report: COVIDIEN 30318 AQUA-SEAL CDU; CHEST DRAINAGE UNIT

Model Number 8888571299

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date 6/10/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a chest drainage unit.The customer states the corrugated tube is out of the joint to the drain chamber which can cause a collapse of the tube.

Manufacturer Narrative

The complaint report indicates that no sample is available in connection with this complaint report.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process of lot 15i160fhx.There were photos attached to the complaint which shows the tube is not connected correctly.A potential root cause for this complaint may be that the sleeve was not inserted fully or dislodged post production.A quality alert was initiated to communicate and create understanding of this customer concern to all personnel involved in the manufacturing of this product.Furthermore a formal corrective and preventative action investigation has been initiated to investigate complaints for tubing issues.No further action is required at this time.This complaint will be used fr tracking and trending purposes.

• Brand Name: 30318 AQUA-SEAL CDU
• Type of Device: CHEST DRAINAGE UNIT
• Manufacturer (Section D): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer (Section G): COVIDIEN; sragh industrial estate; county offaly; tullamore ; EI
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5717407
• MDR Text Key: 48162220
• Report Number: 9611018-2016-00016
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8888571299
• Device Catalogue Number: 8888571299
• Device Lot Number: 15I160FHX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2016
• Initial Date FDA Received: 06/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1